This study is a clinical trial on 90 children aged 1-5 years admitted to pediatric clinic in Kashan Beheshti Hospital with complaints of acute watery diarrhea. Children with high fever (T>38.5°C), severe dehydration, bloody diarrhea, severe malnutrition, using of antibiotics, anti-diarrheal or anti-fungal drugs and patients with more than one complain or Immune deficiency are excluded from the study. Patients randomly assign into three groups. Experimental group1 receive conventional yogurt prepared by Pak Company 15 ml/kg/day for 5 days and experimental group 2 receive probiotic yogurt prepared by Pak Company 15 ml/kg/day for 5 days and the control group will receive no yogurt. In three groups, treatment protocols for acute watery diarrhea (using ORS) shall be conducted. Frequency and duration of diarrhea within the past 24 hours is recorded by asking mothers.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2014081311145N12
Registration date:2014-10-26, 1393/08/04
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2014-10-26, 1393/08/04
Registrant information
Name
Mohammad Reza Sharif
Name of organization / entity
Kashan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 31 5554 0026
Email address
sharif_m@kaums.ac.ir
Recruitment status
Recruitment complete
Funding source
Kashan University of Medical Sciences
Expected recruitment start date
2014-10-23, 1393/08/01
Expected recruitment end date
2015-08-23, 1394/06/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing the effect of conventional and probiotic yogurts on duration of acute watery diarrhea in children
Public title
The effect of conventional and probiotic yogurts on acute watery diarrhea in children
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Children admitted to pediatric clinic in Kashan Beheshti Hospital with complaints of acute watery diarrhea; Aged 1-5 years Exclusion criteria: High fever (T>38.5°C); Severe dehydration; Bloody diarrhea; Severe malnutrition; Using of antibiotics, anti-diarrheal or anti-fungal drugs; Patients with more than one complain; Immune deficiency
Age
From 1 year old to 5 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
90
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Kashan University of Medical Sciences
Street address
Kashan University of Medical Sciences, Ghotbe Ravandi Blvd, Kashan, Iran
City
Kashan
Postal code
Approval date
2014-10-15, 1393/07/23
Ethics committee reference number
134/
Health conditions studied
1
Description of health condition studied
Acute watery diarrhea
ICD-10 code
A09.9
ICD-10 code description
Gastroenteritis and colitis of unspecified origin
Primary outcomes
1
Description
Duration of diarrhea
Timepoint
Daily
Method of measurement
Stool chart
2
Description
Frequency of diarrhea
Timepoint
Daily
Method of measurement
Counting the number of stools
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group 1: Oral administration of conventional yogurt, 15 mg/kg daily for 5 days plus ORS
Category
Treatment - Drugs
2
Description
Intervention group 2: Oral administration of probiotic yogurt, 15 mg/kg daily for 5 days plus ORS
Category
Treatment - Drugs
3
Description
Control group: Administration of ORS without yogurt